BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2151838 · Received July 6, 2011

    Report

    Report Number
    2531779-2011-04718
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE VIBRATION FEATURE WAS NOT WORKING. THE PUMP WAS OPENED AND THERE WAS NO ELECTRICAL CONNECTION TO THE VIBRATION MOTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDS TO PRESS ON THE BUTTONS SEVERAL TIMES TO GET THEM TO WORK. NO ADDITIONAL INFORMATION IS AVAILABLE. THE COMPLAINT IS BEING REPORTED BECAUSE UNRESPONSIVE BUTTONS HAVE BEEN KNOWN TO DELAY BOLUS DELIVERY IF THE PATIENT IS NOT PREPARED TO DELIVER INSULIN VIA AN ALTERNATIVE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1